SCLC Clinical Trial
Official title:
A Randomized, Multicenter, Open-Label, Phase Ib Study to Evaluate Efficacy, Safety and Tolerability of IBI110 in Combination With Sintilimab Plus Etoposide and Platinum or Carboplatin in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
IBI110 is an investigational drug under evaluation for treatment of small cell lung cancer. The purpose of the study was to assess the Efficacy and Safety of IBI110 in combination with Sintilimab and chemotherapy with untreated ES-SCLC.
This Phase II, multicenter, open-lable study is designed to evaluate the safety and efficacy of IBI110 (anti-lymphocyte activation gene 3 [LAG-3] monoclonal antibody) and sintilimab (anti-programmed death 1 [PD-1] antibody) in combination with intravenous (IV) cisplatin/carboplatin plus (+) etoposide (EP) in treatment naïve patients with extensive-stage small cell lung cancer (ES-SCLC) . Sixty eligible subjects will be enrolled and randomized in a 1:1 ratio to the experimental arm or the control arm. The experimental arm will be IBI110+ sintilimab + EP Q3W for 4 cycles, followed by IBI110+ sintilimab Q3W until disease progression. The control arm will be sintilimab + EP Q3W for 4 cycles, followed by sintilimab Q3W until disease progression. ;
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